NCT04894838 DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
| NCT ID | NCT04894838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Antonius Hospital |
| Condition | Obesity, Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-05-01 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years; * BMI ≥40 kg/m2 or BMI ≥35 kg/m2 with obesity related comorbidity; * Weight regain or insufficient weight loss (EWL\<50% or TWL\<20%)15,16 following RYGB; * Multidisciplinary team screening at one of the bariatric centres; * Informed consent and willing to enter the follow-up program. Exclusion Criteria: * Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation \>50 mL, gastro-gastric fistula, gastro-jejunostomy); * Distalisation of RYGB is technical infeasible (judgment by surgeon); * Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea; * Severe concomitant disease (such as carcinomas and neurodegenerative disorders); * Pregnant women; * Noncompliance in follow-up or unwilling to undergo surgery; * Inability of reading/understanding and filling out questionnaires.
Contact & Investigator
M.J. Wiezer, PhD, MD
PRINCIPAL INVESTIGATOR
St. Antonius Hospital
Frequently Asked Questions
Who can join the NCT04894838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04894838 currently recruiting?
Yes, NCT04894838 is actively recruiting participants. Contact the research team at l.tolenaars@antoniusziekenhuis.nl for enrollment information.
Where is the NCT04894838 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Eindhoven, Netherlands, Roosendaal, Netherlands, Tilburg, Netherlands and 4 additional locations.
Who is sponsoring the NCT04894838 clinical trial?
NCT04894838 is sponsored by St. Antonius Hospital. The principal investigator is M.J. Wiezer, PhD, MD at St. Antonius Hospital. The trial plans to enroll 150 participants.
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